Johnson & Johnson (NYSE: JNJ) is having a rough couple of weeks. Last week, the Food and Drug Administration turned down its request to expand the label of its antibiotic Doribax, and on Tuesday, the company said the agency hadn't approved paliperidone palmitate, its schizophrenia treatment.
The company didn't say why the FDA had turned it down, but did say the agency wasn't requiring any additional clinical studies. It'll work on answering the FDA's questions, and investors probably hope the delay won't be too long.
Paliperidone palmitate seems to be a once-monthly version of Johnson & Johnson's Invega, which has already been approved. Using Elan's (NYSE: ELN) NanoCrystal technology, the drug releases slowly into the bloodstream, so it only has to be injected once per month. That's not a bad quality to have in a drug for schizophrenics, who are notoriously bad about going off their medication, and could be a strong selling point against other atypical antipsychotics, like Eli Lilly's (NYSE: LLY) Zyprexa or AstraZeneca's (NYSE: AZN) Seroquel.
Ironically, one of Johnson & Johnson's other partners may have cheered the FDA's decision. Alkermes (Nasdaq: ALKS) receives manufacturing revenue and royalties from sales of Risperdal Consta, Johnson & Johnson's other extended-release antipsychotic. Presumably, Johnson & Johnson's plan is to try to get patients to switch from Risperdal Consta to the new drug, just as it had hoped that patients would switch from Risperdal to Invega, in anticipation of Risperdal going off-patent.
Perhaps the reason Johnson & Johnson is having such bad luck with the FDA is because it keeps trying to get drugs through FDA divisions that, it seems, have cracked down on approvals. A couple of antibiotics have failed to win approval from the agency, and both Eli Lilly's long-lasting injection of Zyprexa and Vanda Pharmaceuticals' (Nasdaq: VNDA) iloperidone, also for schizophrenia, were denied marketing approval earlier this year.
While we can't know exactly what the FDA's problem is, I think the extended-release paliperidone palmitate will eventually be approved. Though the extended wait isn't what Johnson & Johnson had hoped for, given its large, diverse offerings, the temporary rejection shouldn't hurt the company too much.
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